Tarsus Presents New Findings from Two Studies Demonstrating the Impact of Demodex Blepharitis at the ARVO 2022 Annual Meeting

Rhea-AI Summary

Tarsus Pharmaceuticals (NASDAQ: TARS) presented findings from the Atlas Continuation study, highlighting the burden of Demodex blepharitis on patients' lives at the ARVO 2022 Annual Meeting. The research showcases the need for effective treatments, as current options are inadequate. Furthermore, Tarsus plans to submit a New Drug Application for its lead treatment, TP-03, which showed positive results in pivotal trials involving 833 patients. This investigational therapy targets Demodex mites, offering hope for millions suffering from this condition.

Positive

• TP-03 demonstrated positive results in two pivotal trials with statistical significance.
• Plans to submit a New Drug Application (NDA) for TP-03 to the FDA later this year.
• The potential market size for TP-03 could be large, addressing an unmet need in eye care.

Negative

• Currently, there are no FDA-approved treatments for Demodex blepharitis, indicating market competition risks.
• Existing management tools are ineffective, highlighting a challenging treatment landscape.

IRVINE, Calif., May 05, 2022 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, presented data from its Atlas Continuation study on the negative impact Demodex blepharitis has on daily life and visual function among certain patient groups, as well as preliminary findings from the Pandora study on coexisting bacterial burden for patients with Demodex blepharitis. Both studies were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Meeting.

Accepted abstracts include:

• The Impact of Demodex Blepharitis on Patients and Healthcare System: Results from the Atlas Continuation Study; Blake Simmons, O.D., et al.
• Demodex Blepharitis and Coexisting Bacterial Burden in Eye Care Patients: The Pandora Study; Kiersten Snyder, M.D., et al.

“This research reinforces the significant burden and clinical impact of Demodex blepharitis, particularly among the most commonly seen patients in eye care practices,” said Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus. “We also recently announced strong, positive topline results from our second pivotal trial, Saturn-2, studying our lead investigational therapeutic, TP-03, for the treatment of Demodex blepharitis. With this positive data, we plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) later this year, which is exciting for eye care professionals and the millions of patients suffering from this disease without an effective treatment option. We are committed to advancing our path forward to bring a potential definitive standard of care to these patients in need.”

About TP-03
TP-03 (lotilaner ophthalmic solution, 0.25%) is a novel, investigational therapeutic designed to resolve the signs of Demodex blepharitis by targeting and eradicating the root cause of the disease – Demodex mite infestation. Lotilaner is a well-characterized anti-parasitic agent that paralyzes and eradicates Demodex mites by selectively inhibiting the GABA-Cl channels. It is a highly lipophilic molecule, which may promote its uptake in the oily sebum of the eyelash follicle where the mites reside. TP-03 was evaluated in two pivotal trials collectively involving 833 patients. Both trials met the primary and all secondary endpoints, with statistical significance and no serious treatment-related adverse events. Both trials also demonstrated that TP-03 was generally safe and well-tolerated. If approved, TP-03 may offer treatment for millions of patients with Demodex blepharitis.

About Demodex Blepharitis
Blepharitis is a common lid margin disease that is characterized by eyelid margin inflammation, redness and ocular irritation. Demodex blepharitis is caused by an infestation of Demodex mites, the most common ectoparasite found on humans and accounts for over two-thirds of all blepharitis cases. Demodex blepharitis may affect as many as 25 million Americans based on an extrapolation from the Titan study indicating 58% of patients presenting to U.S. eye care clinics have collarettes, a pathognomonic sign of Demodex infestation, and that at least 45 million people annually visit an eye care clinic. Demodex blepharitis can have a significant clinical burden and negatively impact patients’ daily lives. The Titan study also showed that current management tools, such as tea tree oil and lid wipes, are ineffective at treating Demodex blepharitis. Currently, there are no FDA-approved treatments for Demodex blepharitis.

About Tarsus Pharmaceuticals, Inc.
Tarsus Pharmaceuticals, Inc. applies proven science and new technology to revolutionize treatment for patients, starting with eye care. Tarsus is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology, and infectious disease prevention. Tarsus is studying two investigational medicines in clinical trials. Its lead product candidate, TP-03, is a novel therapeutic which has demonstrated positive results in two pivotal trials for the treatment of Demodex blepharitis. TP-03 is also being developed for the treatment of Meibomian Gland Disease. In addition, Tarsus is developing TP-05, an oral, non-vaccine therapeutic for the prevention of Lyme disease, which is currently being studied in a Phase 1b clinical trial.

Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding the potential market size for TP-03, future events and Tarsus’ plans for and the anticipated benefits of its product candidates including TP-03, the timing, objectives and results of the clinical trials including the potential complete clinical results of the Saturn-2 trial, anticipated regulatory and development milestones and the quotations of Tarsus’ management. The words, without limitation, “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Further, there are other risks and uncertainties that could cause actual results to differ from those set forth in the forward-looking statement and they are detailed from time to time in the reports Tarsus files with the Securities and Exchange Commission, including Tarsus’ Form 10-K for the year ended December 31, 2021 filed on March 14, 2022 with the SEC, which Tarsus incorporates by reference into this press release, copies of which are posted on its website and are available from Tarsus without charge. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Any forward-looking statements contained in this press release are based on the current expectations of Tarsus’ management team and speak only as of the date hereof, and Tarsus specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts:
Media Contact:
Adrienne Kemp
Sr. Director, Corporate Communications
(949) 922-0801
akemp@tarsusrx.com

Investor Contact:
David Nakasone
Head of Investor Relations
(949) 620-3223
DNakasone@tarsusrx.com

FAQ

What did Tarsus Pharmaceuticals present at the ARVO 2022 Annual Meeting?

Tarsus presented findings from the Atlas Continuation study, emphasizing the impact of Demodex blepharitis on patients.

What are the results from Tarsus' pivotal trials for TP-03?

TP-03 showed positive results in pivotal trials, meeting all primary and secondary endpoints.

When does Tarsus plan to submit the NDA for TP-03?

Tarsus plans to submit the NDA to the FDA later this year.

What is Demodex blepharitis?

Demodex blepharitis is caused by an infestation of Demodex mites which leads to eyelid inflammation and irritation.

How many patients could benefit from TP-03?

TP-03 could potentially benefit millions of patients suffering from Demodex blepharitis.